News on diagnostic systems for drugs of abuse and toxicology.
UPenn researchers believe that their lateral flow assay has the potential to be the first point-of-care test that can detect fentanyl and its metabolite, norfentanyl, at clinically relevant cutoffs.
The FDA-cleared and CE-marked assay detects both fentanyl and norfentanyl, allowing labs to identify more true positives, according to Siemens.
Since FDA's actions, the company has implemented a program in which customers must sign a certification letter saying they are using its products as intended.
The firm plans to launch 10 new products next year, but analysts were cautious about Quidel's prospects moving forward.
The Oakland, California-based company will use the funding to speed the manufacturing and commercialization of its dual alcohol and marijuana breathalyzer.